Immunoassay Market Size, Share, Trends, Industry Analysis Report: By Product (Reagents & Kits, Analyzers/Instruments, and Software & Services), Technology, Specimen, Application, End User, and Region (North America, Europe, Asia Pacific, Latin America, and Middle East & Africa); Market Forecast, 2024–2032
- Published Date:Sep-2024
- Pages: 119
- Format: PDF
- Report ID: PM5069
- Base Year: 2023
- Historical Data: 2019-2022
Immunoassay Market Outlook
The immunoassay market size was valued at USD 34.22 billion in 2023. The market is anticipated to grow from USD 36.01 billion in 2024 to USD 54.85 billion by 2032, exhibiting a CAGR of 5.4% during 2024–2032.
Immunoassay Market Overview
The growing prevalence of chronic diseases drives the global immunoassay market. The burden of chronic diseases is increasing globally, with the World Health Organization (WHO) estimating that chronic diseases are responsible for 61% of all deaths and is expected to increase to 70% by 2030. Chronic diseases such as diabetes, cardiovascular conditions, and cancer often require early detection to manage and treat effectively. Immunoassays help in identifying biomarkers associated with these conditions, allowing for earlier diagnosis and intervention.
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The rising incidence of infectious diseases is propelling the immunoassay market. Increased cases of infectious diseases necessitate more extensive surveillance and screening programs. Immunoassays are used in these programs to detect infections in large populations, helping in early detection, containment, and control measures.
Immunoassay Market Drivers
Rising Biotechnology Industry
Biotechnology companies are heavily involved in the research and development (R&D) of new drugs, therapies, and diagnostic tools. Immunoassays are fundamental in R&D processes for detecting and quantifying biomarkers, assessing drug efficacy, and studying disease mechanisms. Therefore, the rising biotechnology industry boosts the global immunoassay market growth.
Growing Technological Advancements
Technological innovations such as automated platforms and microfluidics enable high-throughput screening, allowing for the simultaneous analysis of many samples. This efficiency is particularly valuable in research, drug development, and large-scale clinical studies, driving demand for advanced immunoassay technologies. Thus, the rising technological advancements propel the immunoassay market.
Immunoassay Market Restraints
Stringent Regulation in Product Development and Validation is Estimated to Impede the Market Growth
Stricter regulatory standards often mean higher costs associated with the development, validation, and testing of immunoassay instruments and consumables. These increased costs may be a barrier to entry for some companies, particularly smaller or newer firms, potentially limiting innovation and market competition. Therefore, the rising stringent regulations hinder the immunoassay market growth.
Immunoassay Market Segment Analysis
Immunoassay Market Breakdown – Product Analysis
Reagents and Kits Segment Dominated Market in 2023
The reagents and kits segment dominated the immunoassay market in 2023 due to its critical role in the performance and reliability of diagnostic tests. These products include various antibodies, antigens, and other essential components required for conducting assays. The ongoing expansion of healthcare and research sectors fuels the demand for these items, as they are integral to the development and implementation of new and established diagnostic methodologies. Additionally, continuous innovation and product launches contribute to the sustained dominance of this segment. In May 2023, Creative Diagnostics announced the launch of SARS-CoV-2 immunoassay kits for research.
The software & services segment is expected to grow at a robust pace in the coming years owing to the increasing complexity of assays, the rising need for streamlined data management, and the growing emphasis on automation and digital integration in laboratories. Software tools enhance the efficiency and accuracy of diagnostic processes by facilitating sophisticated data analysis and real-time monitoring, which aligns with the industry's push toward high-throughput testing and personalized medicine.
Immunoassay Market Breakdown – Technology Analysis
Enzyme Immunoassays Segment Accounted for Largest Market Share in 2023
In 2023, the enzyme immunoassays (EIA) segment held the largest share of the immunoassay market. This is primarily due to the versatility and broad applicability of EIA techniques, which include enzyme-linked immunosorbent assays (ELISA) and similar methods. EIA’s widespread use in clinical diagnostics, research, and routine laboratory testing contributes significantly to its market lead. The ability of EIA to provide quantitative results with high sensitivity and specificity makes it a preferred choice for detecting a variety of biomarkers across multiple applications. Furthermore, advancements in EIA technologies such as the development of robust and cost-effective reagents and automation of processes, enhance its utility and drive its continued dominance.
The rapid test segment is expected to grow at a rapid pace during the forecast period, owing to the increasing demand for quick and reliable diagnostic solutions. Rapid tests, including lateral flow assays and point-of-care devices, offer the advantage of delivering results in minutes rather than hours, making them highly valuable in emergency and outpatient settings. The drive toward more accessible and user-friendly diagnostic tools, especially in resource-limited settings and during outbreaks of infectious diseases, supports the growth of rapid testing technologies. Moreover, ongoing innovations in test design and materials are likely to enhance the performance and range of applications for rapid tests, further positioning them as a growing segment of the market.
Immunoassay Market Breakdown – Specimen Analysis
Blood Specimen Segment Held Significant Market Revenue Share in Immunoassay Market
The blood specimen segment held a significant share in the immunoassay market in 2023 due to its critical role in a large number of diagnostic and research applications. Blood samples are central to many assays as they provide a comprehensive overview of an individual's health status, allowing for the detection of a wide range of biomarkers, from infectious agents to chronic disease indicators. The extensive use of blood in routine tests, such as complete blood counts and panels for various diseases, highlights its dominance. Additionally, advancements in blood collection and processing technologies, along with the integration of sophisticated assays that require minimal sample volume, have strengthened the segment's strong market presence.
The urine segment is projected to grow at a significant CAGR in the coming years owing to the growing recognition of urine as a noninvasive, easily accessible specimen that provides valuable diagnostic information. Advances in urine-based assays have expanded their applications from traditional uses, such as pregnancy testing and routine drug screenings, to diabetes and kidney testing. The development of highly sensitive and specific urine tests that detect a variety of biomarkers efficiently and cost-effectively contributes to this projected growth. Moreover, the increasing preference for noninvasive diagnostic methods in clinical and at-home settings supports the rising dominance of urine-based assays.
Immunoassay Market Breakdown – Regional Insights
North America Registered Largest Share of Global Market in 2023
North America held the dominant share in the immunoassay market in 2023. This is due to its advanced healthcare infrastructure, high investments in research and development, and strong regulatory environment. The presence of major diagnostic companies, coupled with a high prevalence of chronic diseases and a robust healthcare system that supports extensive diagnostic testing, reinforces North America’s leading position. The region's focus on innovation and technological advancements further boosts its market dominance, ensuring the continual expansion of diagnostic solutions. For instance, in April 2024, the US Food and Drug Administration (FDA) approved Abbott's whole blood rapid test to evaluate the risk of a suspected mild traumatic brain injury within 15 minutes.
Asia Pacific is expected to be the fastest-growing region during the forecast period, owing to the expanding healthcare infrastructure, increasing investments in medical technology, and a rising burden of chronic and infectious diseases. Countries such as China and India are driving the regional market growth as they have large populations, rapid economic development, and increasing healthcare expenditures. The growth of the Asia Pacific immunoassay market is also supported by improvements in healthcare access and the expansion of diagnostic services in urban and rural areas. Additionally, the region’s emphasis on enhancing healthcare quality and increasing the adoption of advanced diagnostic technologies contributes significantly to its projected market leadership.
Key Market Players and Competitive Insights
Major market players are investing heavily in research and development to expand their offerings, which will drive the immunoassay market during the forecast period. Market participants are also undertaking a variety of strategic activities to expand their global footprint, with important market developments such as innovative launches, international collaborations, higher investments, and mergers and acquisitions between organizations. Major players in the immunoassay market are BD; Bio-Rad Laboratories, Inc.; Siemens Healthineers; Abbott; and Thermo Fisher Scientific, Inc.
Major Players Operating in Global Immunoassay Market
- Abbott
- BD
- Beckman Coulter
- Bio-Rad Laboratories, Inc.
- bioMérieux SA
- F. Hoffmann-La Roche AG
- Ortho Clinical Diagnostics
- Quidel Corporation
- Siemens Healthineers
- Sysmex Corporation
- Thermo Fisher Scientific, Inc.
Recent Developments in the Industry
- In July 2023, Siemens Healthineers announced the launch of the Atellica CI Analyzer after receiving approval from the Food and Drug Administration. It is used for immunoassay testing and clinical chemistry.
- In March 2023, Quidel Corporation received approval from the US FDA to market Sofia 2 SARS Antigen+ FIA. It is the first rapid antigen for COVID-19 to be used in point-of-care settings.
Report Coverage
The immunoassay market report emphasizes key regions across the globe to provide a better understanding of the product to the users. Also, the report provides market insights into recent developments and trends and analyzes the technologies that are gaining traction around the globe. Furthermore, it covers an in-depth qualitative analysis pertaining to various paradigm shifts associated with the transformation of these solutions.
The report provides a detailed analysis of the market while focusing on various key aspects such as competitive analysis, product, technology, specimen, application, end user, and their futuristic growth opportunities.
Report Segmentation
The immunoassay market is primarily segmented on the basis of product, technology, specimen, application, end user, and region.
By Product Outlook (Revenue, USD Billion, 2019–2032)
- Reagents & Kits
- ELISA Reagents & Kits
- Rapid Test Reagents & Kits
- ELISPOT Reagents & Kits
- Western Blot Reagents & Kits
- Other Reagents & Kits
- Analyzers/Instruments
- Open Ended Systems
- Closed Ended Systems
- Software & Services
By Technology Outlook (Revenue, USD Billion, 2019–2032)
- Radioimmunoassay (RIA)
- Enzyme Immunoassays (EIA)
- Chemiluminescence Immunoassays (CLIA)
- Fluorescence Immunoassays (FIA)
- Rapid Test
- Others
By Specimen Outlook (Revenue, USD Billion, 2019–2032)
- Blood
- Saliva
- Urine
- Other Specimens
By Application Outlook (Revenue, USD Billion, 2019–2032)
- Therapeutic Drug Monitoring
- Oncology
- Cardiology
- Endocrinology
- Infectious Disease Testing
- Autoimmune Diseases
- Others
By End User Outlook (Revenue, USD Billion, 2019–2032)
- Hospitals
- Blood Banks
- Clinical Laboratories
- Pharmaceutical and Biotech Companies
- Academic Research Centers
- Others
By Regional Outlook (Revenue, USD Billion, 2019–2032)
- North America
- US
- Canada
- Europe
- Germany
- UK
- France
- Italy
- Spain
- Russia
- Netherlands
- Asia Pacific
- China
- India
- Japan
- South Korea
- Indonesia
- Malaysia
- Latin America
- Argentina
- Brazil
- Mexico
- Middle East & Africa
- UAE
- Saudi Arabia
- Israel
- South Africa
Immunoassay Market Report Scope
|
Report Attributes |
Details |
|
Market Size Value in 2024 |
USD 36.01 billion |
|
Revenue Forecast by 2032 |
USD 54.85 billion |
|
CAGR |
5.4% from 2024 to 2032 |
|
Base Year |
2023 |
|
Historical Data |
2019–2022 |
|
Forecast Period |
2024–2032 |
|
Quantitative Units |
Revenue in USD billion and CAGR from 2024 to 2032 |
|
Segments Covered |
|
|
Regional Scope |
|
|
Competitive Landscape |
Immunoassay Industry Trend Analysis (2023) Company Profiles/Industry participants profiling includes company overview, financial information, product/service benchmarking, and recent developments |
|
Report Format |
PDF + Excel |
|
Customization |
Report customization as per your requirements with respect to countries, regions, and segmentation. |
FAQ's
The global immunoassay market size was valued at USD 34.22 billion in 2023 and is projected to grow to USD 54.85 billion by 2032.
The global market is projected to register a CAGR of 5.4% during the forecast period.
North America held the largest share of the global market in 2023.
Abbott; BD; Beckman Coulter; Bio-Rad Laboratories, Inc.; bioMérieux SA; F. Hoffmann-La Roche AG; Ortho Clinical Diagnostics; Quidel Corporation; Siemens Healthineers; Sysmex Corporation; and Thermo Fisher Scientific, Inc. are among the key players in the market.
The software & services product segment is projected for significant growth in the global market during the forecast period.
The blood specimen segment dominated the market in 2023.
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